November 3, 2011 at 12:05 PM by cdisc

The CDISC International Interchange 2011 was held again in the heart of Baltimore, MD at the Renaissance Harborplace Hotel, what an amazing location! The Interchange this year was quite rich of knowledge and information that many of you have missed if you could not attend. But, we are happy to share some of this information to keep you informed of our progress and to maintain your participation in our global mission, with a vision towards “Informing patient care and safety through higher quality medical research”. We are in a technology developing era that is fast-paced. Each day is a treasure for us to make use of the time towards the continuous progress of our CDISC projects. We are committed to utilizing our data standards wisely and efficiently for the humanitarian purpose of streamlining the development of cure for patients. During this year’s International Interchange, CDISC had a set of Colloquia sessions where many FDA folks were happy to be involved, providing their input on the work they do for the sake of patients and public health and how adopting the CDISC Standards ensures global consistency by avoiding errors and loss of time. The Colloquia was made possible by C-Path, ACRP & APPI.

The first colloquia session that I attended was on Tuesday, 11 October. It focused on the Virology domains and datasets. There was an FDA presenter, Helena Sviglin, who had drafted the initial Virology domains for comment. There were also 3 FDA reviewers attending this session, along with CDISC team members and experts from other organizations. Ms. Sviglin was happy to share the updates with us and was asking for comments from the attendees. She started off the session by telling us that they work with Dr. Chuck Cooper on validating data efforts of any of the review divisions; Dr. Cooper is an FDA reviewer, MD, in the Office of Translational Sciences, CDER, FDA.

Ms. Sviglin pointed out that there are a number of applications in the pipeline for Hepatitis C and antiviral medications, and the FDA had learned a lesson (before she came on board) that there is a lot of specific data being collected in these antiviral trials, which currently has no good ‘home’ for it in SDTM. So, they are trying to develop these kinds of standards for Hep C and HIV, since there is an ongoing project within the FDA to convert the data from 51 HIV trials into an SDTM format so that they can be stacked and analyzed, looking for safety and efficacy on a drug class level.

Ms. Sviglin continued by mentioning that these certain kinds of Genotypic and Phenotypic data did not have a really good way to map into SDTM, so taking into consideration the time, the solution was to try to fit them into the MB (Microbiology domain). It has become clear that it is not the ideal place for these data, so they (FDA) decided to develop some domain structures that could specifically accommodate this kind of data. Ms. Sviglin asked the attendees to join and help lead this effort. She pointed out that they interface with CDISC through Phil Pochon and Joyce Hernandez; Phil is the CDISC LAB Team Leader, and Joyce is also a very active CDISC team member in Clinical Genomics and SDTM. Phil and Joyce are involved in the development of the PGX (pharmacogenomics) domain, which is a compilation of domains designed to capture pharmacogenomics data for the subject. There are about 5 or 6 domains designed to capture a number of different types of data elements involved in the specific collection, processing and assessment of these samples.

FDA is trying to recreate some of these domains for the pathogen data and design them to capture different types of data elements involved in the collection, processing and assessment of the samples just as the ones mentioned previously. They have collaborated to propose 2 domain structures to try to introduce SDTM specifically for Virological Genotypic and Virological Phenotypic data. The first Colloquia met in March and did some early work on Hepatitis C structure. Ms Sviglin thinks that the main lesson from this work is the need to define some terms; she stated: “because we all have our different scientific backgrounds and we don’t always call the same concepts-- even simple things like gene, mutation, target, proteins, enzymes, we all use them sometimes interchangeably with different definitions and we were talking across each other a lot at the table, so at some point we just wrote a few definitions”. She also mentioned that Chris Tolk, the CDISC Terminology team lead and a member of the CDISC SDTM team was the transcriber for the prior Hep C Colloquium during which she captured some of the basic definitions along with minutes of that meeting. Since that last set of Colloquia, FDA developed DRAFT Virology SDTM domains, which CDISC sent out for public comments. They got quite a lot of feedback, which would be a good place for this Colloquium to start!

This Colloquium was a great time and place for team members to have some face time with the FDA reviewers—to truly understand what they do and wish to do in reviewing eSubmission data. I think that this was an excellent meeting, and we hope to have more global participation in the future towards the development of the Virology-specific standards and domains. FDA has posted a ‘wish list’ for standards to support numerous therapeutic areas. It is for this reason that (as a new step), CDISC posted DRAFT Virology domains for comment prior to the Colloquia so that there would be broad input gathered in advance of this meeting. We need to streamline the process to ensure that there is hope of achieving our ultimate goal of developing cures faster for patients all around the globe!

Baltimore is such an amazing and convenient location to have the CDISC International Interchange at, we hope to see you there next year for the CDISC International Interchange 2012! Enjoy the Photos!